PolarityTE Announces Successful Completion of Initial Pre-IND Interaction with U.S. Food and Drug Administration for SkinTE

PolarityTE, Inc. (Nasdaq: PTE) announced that it recently received written responses from FDA following a Type B Pre-IND meeting request that the Company submitted in August 2020 regarding an indication for SkinTE to treat diabetic foot ulcers (DFUs). FDA’s responses included, among other things, feedback and recommendations on SkinTE manufacturing, preclinical studies, clinical data submitted in the Company’s briefing package, and additional clinical studies to support our IND submission. The Company expects to discuss additional indications in pressure injuries and traumatic wounds with FDA in the coming months. Based on the FDA input gathered in these interactions, the Company plans to prepare and submit an IND to enable clinical studies for one or more indications in the second half of 2021.

The Company believes that the guidance and recommendations received from FDA provide a well-defined regulatory pathway, and plans to proceed with IND-enabling activities over the coming months. In addition, the Company is developing a strategy to pursue multiple indications based on its continuing dialog with the FDA regarding the DFU indication, and additional planned meetings regarding other indications.

The Company previously announced that it will report earnings for calendar third quarter 2020 on November 9, 2020, and plans to provide additional detail and discuss the FDA’s feedback during the earnings call on November 9, 2020 at 8:00 a.m. Eastern Time. A webcast of the conference call can be accessed by using the link below.

Earnings Call Webcast – CLICK HERE

Richard Hague, President and Chief Operating Officer, commented: “We are pleased to have received helpful feedback from FDA regarding SkinTE for treatment of DFUs, and we believe that FDA’s responses generally track established guidance for sponsors of biologics. We plan to continue our dialog with FDA over the coming months as we work to finalize our development plan for DFUs and other indications such as trauma and pressure wounds.”

About PolarityTE

PolarityTE is focused on transforming the lives of patients by discovering, designing, and developing a range of regenerative tissue products and biomaterials for the fields of medicine, biomedical engineering and material sciences. Rather than manufacturing with synthetic and foreign materials within artificially engineered environments, PolarityTE manufactures products from the patient's own tissue and uses the patient's own body to support the regenerative process. From a small piece of healthy autologous tissue, the company creates an easily deployable, dynamic, and self-propagating product designed to regenerate the target tissues. PolarityTE's innovative methods are intended to promote and accelerate growth of the patient's tissues to undergo a form of effective regenerative healing. Learn more at www.PolarityTE.com – Welcome to the Shift.